This invention relates to devices and methods for controlling female incontinence and more particularly to a novel female incontinence control device that employs a manually actuatable valve for controlling urinary discharge, and a novel method of controlling urinary discharge.
Urinary incontinence, or the loss of bladder control, is a problem that many women cope with on a daily basis. Female urinary incontinence often results from muscle weakness, post-operative surgical damage to the urinary sphincter or a variety of other debilitating problems. Thus far there have been no satisfactory surgical procedures for correcting incontinence to the extent that bladder control is substantially restored.
Some known devices that deal with the problem of female incontinence allow the bladder to continuously drain into a collection bag and thus do not enable the user to adequately control urinary discharge. Other known devices which are directed to the problem of female incontinence attempt some form of drainage control and include catheters, draining probes and dilators, such as shown in U.S. Pat. Nos. 4,194,508; 4,198,979 and 4,563,183. Generally such known devices also include an external fluid collection system fastened to a portion of the users body. Unfortunately, a collection system that is carried by a user inhibits the users activities and can provide a path for bacterial infection.
Not only are catheters, collection bags, and absorbent pads awkward to use in dealing with incontinence they are often a potential source of embarrassment to the user. Attempts to address such problems as lack of control, bulkiness, discomfort, embarrassment and inhibition of activity have led to the development of valved incontinence control devices, which eliminate the need for external collection systems and allow the user to manually control the flow of urinary fluids from the urinary tract. Examples of such devices are shown in U.S. Pat. Nos. 3,503,400, 3,939,821 and 4,024,855.
In U.S. Pat. No. 3,503,400 a manually controllable valve is positioned within the urethra near the bladder. The valve is operated by a control cable that passes through the urethra to permit exterior access by the user. Such an arrangement, although permitting positive drainage control, provides a potential path for bacterial infection of the urinary tract, and can also cause embarrassment to the user due to the fact that the control cable must extend outside the user's body.
In U.S. Pat. Nos. 3,939,821 and 4,024,855 magnetic valve members are surgically implanted about the urethra of the user and require external actuating means to cause the valve to operate. Such devices necessitate surgical implantation of the magnetic valve members, and require the user to be equipped with an external actuating member in order to actuate the valve to accomplish urinary discharge.
It is thus desirable to provide a female incontinence control device that is manually actuatable by the user to control urinary discharge, is relatively comfortable to use and does not unduly impede normal activity of the user.